FDA 483 - Torrent Pharmaceuticals Limited - September 20, 2024

An FDA inspection of Torrent Pharmaceuticals Limited in Pithampur, India, revealed a significant deficiency in quality control. The firm failed to adequately test incoming excipient materials for identity and contamination before their use in finished drug products, specifically a cream distributed to the U.S. market. This indicates a serious lapse in ensuring the quality and safety of drug components.